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NICOTINE

WALGREEN COMPANY

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Nicotine, 21mg delivered over 24 hours

Nicotine, 14mg delivered over 24 hours

Nicotine, 7mg delivered over 24 hours

Stop smoking aid

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Do not use

  • •if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products

Ask a doctor before use if you have

  • •heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
  • •high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
  • •an allergy to adhesive tape or have skin problems because you are more likely to get rashes

Ask a doctor or pharmacist before use if you are

  • •using a non-nicotine stop smoking drug
  • •taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

When using this product

  • •do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch.
  • •if you have vivid dreams or other sleep disturbances remove this patch at bedtime

Stop use and ask a doctor if

  • •skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash
  • •irregular heartbeat or palpitations occur
  • •you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness, and rapid heartbeat

Keep out of reach of children and pets.

Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.

  • if you are under 18 years of age, ask a doctor before use
  • •before using this product, read the enclosed User’s Guide for complete directions and other information
  • •stop smoking completely when you begin using the patch
  • if you smoke more than 10 cigarettes per day, use according to the following 10-week schedule:

STEP 1

STEP 2

STEP 3

Use one 21mg patch/day

Use one 14mg patch/day

Use one 7mg patch/day

Weeks 1-6

Weeks 7-8

Weeks 9-10

  • •if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg) for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop.
  • •steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.
  • •apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.
  • •remove backing from patch and immediately press onto skin. Hold for 10 seconds.
  • •wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling.
  • •you may wear the patch for 16 or 24 hours
  • •if you crave cigarettes when you wake up, wear the patch for 24 hours
  • •if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning
  • •the used patch should be removed and a new one applied to a different skin site at the same time each day
  • •do not wear more than one patch at a time
  • •do not cut patch in half or into smaller pieces
  • •do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours
  • •stop using the patch at the end of 10 weeks. If you started with STEP 2, stop using the patch at the end of 8 weeks. If you still feel the need to use the patch, talk to your doctor.

store at 20 – 25oC (68 – 77oF)

ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

call toll-free 1-877-306-0019

(English/Spanish) weekdays (9:00 a.m. – 4:30 p.m. ET)

Compare to NicoDerm® CQ®*

See top panel for lot number and expiration date.

* NICODERM and CQ are trademarks of the GlaxoSmithKline group of companies and other third parties.

Made in Switzerland

Comments/questions:

GCSP 5.4376.4C

Re: Consumer Relations

PO Box 13398

Research Triangle Park, NC 27709-9627

Distributed by:

Walgreen Co.,

200 Wilmot Road

Deerfield, IL 60015-4616

100% Satisfaction Guaranteed with all Walgreens Products or Your Money Back.

www.walgreens.com

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Complete the full treatment program, applying a new patch every day.

3. Use with a support program as described in the enclosed User's Guide.

For your family's protection, nicotine patches are supplied in child-resistant pouches. Do not use if individual pouch/packet is damaged or open.

  • •Not for sale to persons under 18 years of age.
  • •Proof of age required.
  • •Not for sale in vending machines or from any source where proof of age cannot be verified.

Principal Display Panel

NDC 0363-9180-02

CLEAR Nicotine Transdermal System Patch

Walgreens

STEP 1

21mg delivered over 24 hours

STOP SMOKING AID

with Behavior Support Program

If you smoke more than 10 cigarettes per day: start with Step 1

If you smoke 10 or less cigarettes per day: start with Step 2

14 Clear Patches

2 WEEK KIT

©2011

30818XC

Principal Display Panel

NDC 0363-0195-02

CLEAR Nicotine Transdermal System Patch

Walgreens

STEP 2

14mg delivered over 24 hours

STOP SMOKING AID

with Behavior Support Program

If you smoke more than 10 cigarettes per day: start with Step 1

If you smoke 10 or less cigarettes per day: start with Step 2

14 Clear Patches

2 WEEK KIT

©2009

30819XC

Principal Display Panel

NDC 0363-0196-02

CLEAR Nicotine Transdermal System Patch

Walgreens

STEP 3

7mg delivered over 24 hours

STOP SMOKING AID

with Behavior Support Program

For use after completing Step 2

14 Clear Patches

2 WEEK KIT

©2009

30820XA

NICOTINE

nicotine PATCH, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-9180
Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 21 mg

Inactive Ingredients

Ingredient Name Strength
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)
HIGH DENSITY POLYETHYLENE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 PATCH
2 24 in 1 PATCH
3 NDC:0363-9180-01 7 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020165 2010-02-15


NICOTINE

nicotine PATCH, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-0195
Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 14 mg

Inactive Ingredients

Ingredient Name Strength
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)
HIGH DENSITY POLYETHYLENE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 PATCH
2 NDC:0363-0195-02 14 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020165 2010-02-15


NICOTINE

nicotine PATCH, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-0196
Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
nicotine NICOTINE 7 mg

Inactive Ingredients

Ingredient Name Strength
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)
HIGH DENSITY POLYETHYLENE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 PATCH
2 NDC:0363-0196-02 14 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020165 2010-02-15


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Be sure to consult your doctor before taking any medication!
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